Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)|
- To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Patients undergoing HSCT
Research subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment.
Other: Blood Samples
blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.
MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581958
|Contact: Christopher A. Barker, MD||212-639-8168|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Christopher Barker, MD 212-639-8168|
|Contact: Marcel VandenBrink, MD, PhD 646-888-2304|
|Principal Investigator: Christopher Barker, MD|
|Principal Investigator:||Christopher Barker, MD||Memorial Sloan Kettering Cancer Center.|